Regulatory Alert Comorbidities & Linking Strategies - Digitas Health - September 2011

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Regulatory AlertFDA Enforcement Action on Comorbidity & Linking Strategies

September 13, 2011 Analyst: Dale Cooke

EXECUTIVE SUMMARY

The FDA has taken enforcement action against promotional activities by Pfizer that further clarifies FDAs

view on website linking strategies. This action also has implications for the cross-promotion of other products

that treat comorbidities as well as for franchise marketing efforts. Companies should scour existing

promotional activities to ensure there are no mentions of products and indications without relevant risk

information, and avoid mention of specific products as part of their linking strategies.

This violation was reported via the Bad Ad Program. FDAs initiative to encourage health care professionals to

report allegedly violative materials is clearly increasing the frequency of this type of report. Industry needs

to take heed.

BACKGROUND

On August 31, 2011, the Food and Drug Administrations Division of Drug Marketing Advertising and

Communications (DDMAC) issued an untitled letter to Pfizer for its marketing of CADUET (amlodipine

besylate/atorvastatin calcium) Tablets, CHANTIX (varenicline) Tablets, and NORVASC (amlodipine besylate)

Tablets. Specifically, Pfizer had placed on the Lipitor.com website a link to the product sites, along with a

mention of the product names, and an abbreviated description of the product indications. On the webpage,

there was risk information provided for the use of LIPITOR (atorvastatin calcium) Tablets, but there was no

risk information provided for Caduet, Chantix, or Norvasc.

Another item worth noting about this enforcement activity is that FDA again attributed the action to a

complaint to the DDMAC Bad Ad Program.1 The Bad Ad Program, launched in May 2010, encourages

healthcare professionals to report allegedly violative promotional materials to the FDA. FDA has taken steps

to educate healthcare professionals about advertising regulations for prescription drugs. The Agency has

promoted the program via webinars, press releases, and instructional videos.2

So far in 2011, five of DDMACs 21 enforcement actions have been attributed to the Bad Ad Program. Clearly,

this is now a major source for enforcement actions. All members of industry should assume that health care

professionals are more aware of the advertising regulations, and because FDA has made it easier to report

allegedly violative materials, health care professionals are more likely to report them. 3

Use of links has been an ongoing area of interest for the FDA, dating back to the 1996 hearings on the FDA

and the Internet.4 This topic was again on the docket for the November 2009 Part 15 hearings on use of the

Internet and social media tools to promote medical products.5 One of the detailed questions the FDA was

seeking information about was Should parameters be established for links to and from Web sites?6


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RELEVANT FACTS

Lipitor is indicated as an adjunct treatment for high cholesterol for those at increased risk of coronary heart

disease. According to the promotional materials posted by the FDA, the webpage on Lipitor.com included a

listing of other places online where people could learn more about heart health. At the top of the page,Pfizer posted information about other medicines that may help manage other risk factors for heart

disease.7 Following that description were a series of links to the websites for Caduet, Chantix, and Norvasc,

with a brief description of the indications for those medicines as shown8:

CADUET (amlodipine besylate/atorvastatin calcium)

Learn about a treatment for high blood pressure and high cholesterol in a single pill.

CHANTIX (varenicline)

Learn about a prescription drug to help people quit smoking

NORVASC (amlodipine besylate)

Learn about a treatment for high blood pressure and the chest pain of angina

Below this series of links, there was a paragraph about community programs and a list of links to third-party

sites such as the American Heart Association, Centers for Disease Control and Prevention, and Mayo Clinic

with additional information about heart disease.

At the bottom of the page, a larger description of the indication statement for Lipitor was provided followed

by risk information including the contraindications, adverse events, and warnings and precautions.

Nowhere on the page was any risk information about the use of Caduet, Chantix, or Norvasc provided.

According to FDAs letter,9 clicking on the links took site visitors to a further Lipitor.com webpage with a

Click to Continue link. Clicking on that further link took site visitors to the websites for the respective

products, where the full PI was provided.

IMPLICATIONS

The first implication for future marketing efforts is that FDA is reiterating that risk information must be

presented at the same time in the same location as benefit information related to a product.

Second, companies with more than one product in a treatment category who wish to make site visitors aware

of multiple products must ensure that risk information is provided for each specific product whose benefits

are discussed. In the context of a discussion of comorbidities or risk factors, it would be difficult to include

any product names without implying a benefit. Consequently, any mention of a product name in such context

should be assumed to require presentation of risk information. This will be particularly relevant to anyfranchise marketing efforts that promote a companys entire product line within a therapeutic area.

RECOMMENDATIONS

1. Review existing and planned discussions of treatments for comorbidities on product sites.Ensure there is no explicit mention of products and indications (either complete or

abbreviated) without material risk information.


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2. Linking strategies to product pages should avoid mention of the product name withinformation about the indication unless sufficient risk information is provided.10 In context

of comorbidities or the treatment of additional risk factors, special care should be taken.

3. Product sponsors must take into account the extensive reporting of allegedly violativepractices by health care professionals as reports from the Bad Ad Program constitute nearly25% of all enforcement actions taken in 2011.

SUPPLEMENTAL MATERIAL

Bad Ad Program Information on the FDA website:http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm209384.htm

Warning Letters from 2011 (including the letter discussed in this alert) on the FDA website:http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm238583.htm#DDMAC

ENDNOTES

1 MA# 2071, page 1, letter to Pfizer, for promotional materials for Chantix, Caduet, and Norvasc, dated August 31, 2011,last accessed September 13, 2011, fromhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM270607.pdf

2 For information about the first year of the Bad Ad Program and FDAs efforts to promote the program last accessedSeptember 13, 2011, fromhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm258719.htm

3 In its year-end report on the program available from the website listed above, FDA noted that prior to the Bad AdProgram launch, there were 104 reports per year of allegedly violative materials, but there were 328 Bad Ad Programreports, i.e., more than triple the historical average.

4 For information on the discussion of website links at the 1996 hearings, last accessed September 13, 2011, fromhttp://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm175792.htm

5 Information on the November 2009 hearings is available on the FDA website, last accessed September 13, 2011, fromhttp://www.fda.gov/aboutfda/centersoffices/cder/ucm184250.htm

6 See http://edocket.access.gpo.gov/2009/E9-22618.htm for the specific questions FDA wished to address at theNovember 2009 hearings.

7 Promotional material posted with MA# 2071, last accessed September 13, 2011, from

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM270608.pdf

8 MA# 2071, page 4.

9 MA# 2071, page 4.

10 FDA does not provide further explication of what would have constituted sufficient risk information for the productclaims cited in this letter, see page 1, footnote 2.

Documents

Regulatory Alert Comorbidities & Linking Strategies - Digitas Health - September 2011